Cisplatin or ImmunoTHerapy in Association With Definitive Radiotherapy in HPV-related oropharyngE… (NCT03623646) | Clinical Trial Compass
CompletedPhase 2
Cisplatin or ImmunoTHerapy in Association With Definitive Radiotherapy in HPV-related oropharyngEal Squamous Cell Carcinoma: a Randomized Phase II Trial.
France11 participantsStarted 2019-03-15
Plain-language summary
This study is a phase II, multicenter, open-label study that has been designed to evaluate the efficacy and the safety of definitive Radiotherapy (RT) (70 Gy) delivered in combination with the anti-PD-L1 Durvalumab immunotherapy in patients with Human Papilloma Virus (HPV)-related oropharyngeal squamous cell carcinoma.
In this phase II trial, patients will be assigned in one of the two treatment arms:
* Arm A (standard arm): Chemoradiotherapy arm
* Arm B (Experimental arm): Immunotherapy + Radiotherapy arm
Total duration of treatment will be 6 months (at maximum in the experimental arm).
Patients will be followed for a maximum of 2 years following the date of randomization.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Newly diagnosed, histologically proven squamous cell carcinoma of oropharynx T1 N1-N2 or T2-T3 N0 to N2 (AJCC 2018)
✓. HPV positive status (positive staining for p16 in immunochemistry)
✓. Presence of at least one measurable lesion according to RECIST v1.1 criteria (longest diameter recorded ≥10 mm with CT scan)
✓. No prior anticancer therapy for OSCC
✓. Patient eligible for definitive radiochemotherapy
✓. Age ≥ 18 years
✓. WHO performance status \< 2 i.e. 0 or 1
✓. Body weight \>30kg
Exclusion criteria
✕. T1 N0, T1-T3 N3, T4 N0-N3, p16 + OSCC
✕. Previous treatment with another check-point inhibitor
✕
What they're measuring
1
The rate of patients alive without progression at 12 months.
. Other histologies : UCNT, p16- SCCHN, sino-nasal tumors
✕. Patient ineligible for Cisplatin according to the updated SmPC of the drug (including patient with auditory deficiency, patient with neuropathy induced by previous Cisplatin treatment or patient treated with prophylactic phenytoin)
✕. Metastatic disease
✕. Previous radiotherapy, except anterior strictly out of field radiotherapy, received for treatment of another primary tumor considered in remission in the past 5 years
✕. Participation in another therapeutic trial within the 30 days prior to entering this study
✕. Uncontrolled disease such as diabetes, hypertension, symptomatic congestive heart or pulmonary failure, renal or hepatic chronic diseases... (non-exhaustive list)